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Items: 4

1.

Clinical Trials as Topic

Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries..

Year introduced: 2008(1965)

2.

Pragmatic Clinical Trials as Topic

Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.

Year introduced: 2014

3.

Controlled Clinical Trials as Topic

Works about clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.

Year introduced: 2008(1995)

4.

Adaptive Clinical Trials as Topic

Works about clinical studies in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.

Year introduced: 2018

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